Dear Fellow Worriers:

As promised earlier, the following is offered as an attempt to

assess several aspects of our varying approaches to supporting

our compliance responsibilities in regard to the use of humans

and animals associated with sponsored and other activities.

While we have yet to determine a means to analyze and provide a

logical summary (that is happening concurrently with this

posting), we will post and/or return as you wish, the results of

this inquiry.  Needless to say, the issues addressed are of

direct and immediate interest to WVU, and I would hope to you as

well.

Please respond electronically to me xxxxxx@WVNVM.WVNET.EDU or by

FAX at 304-293-7435.  I hope to have an initial summary, or at

least a beginning compilation, within a week or so.

Bill Reeves

Director, Sponsored Programs

West Virginia University

 IRB/IACUC Questionnaire

 Institutional Review Board for the Protection of Human Subjects

1.  Total active IRB protocols

2.  Total IRB protocols in preceding 12 months

 Review Level - Full Board

 Review Level - Expedited

3.  Have you noticed an increase in the number

 of active protocols over the last two years?

4.  On a monthly basis, how many IRB Full Board

 and expedited protocols are submitted

 for review (excluding continuing review)?

 Full Board

 Expedited

5.  On a monthly basis, how many IRB protocols

 are considered for annual continuing review?

 Full Board

 Expedited

 Are these handled the same as initial submissions

 or have you initiated a different process for

 annual continuing review?  Please explain as

 necessary.

6.  Does your IRB review medical protocols,

 academic protocols, or a mixture of both?

7.  How many Boards do you have?

8.  How many members on the Board(s)?

9.  How often does your Board(s) meet?

10. Do you utilize a separate Board for multi-

 center protocols?

11. Do you utilize a separate Board for protocols

 subject to continuing review?

12. What is your definition of adverse event?

13. Do you use a form to report adverse events

 to the IRB?

14. How do you inform investigators when to

 report adverse events?  Is this information

 in your approval letters?

15. Does your application for annual continuing

 review include reporting both expected and

 unexpected adverse events?

16. Please summarize your procedures regarding

 compassionate use?

 Are these always life-threatening circumstances?

 Does your Chair sign off on a compassionate use

 form before compassionate use is granted?

 Institutional Animal Care and Use Committee

1.  Total active IACUC protocols

2.  Total IACUC protocols in preceding 12 months?

 Review Level - Full Committee

 Review Level - Expedited

3.  Have you noticed an increase in active protocols

 over the last two years?

4.  Are all laboratory inspections conducted by your

 responsible veterinary care office, IACUC

 members, or a combination of both?

 1.               2.                  3.

 Please explain as necessary.

5.  What is your process for annual continuing review?

6.  Do you use a form to submit revisions to an

 existing active protocol?

 General

1.  Does the same staff support both the IRB and

 the IACUC? Or is there a separate staff for each?

2.  How many FTE on the support staff to the IRB?

 Professional

 Technical

 Clerical

3.  How many FTE on the support staff to the IACUC?

 Professional

 Technical

 Clerical

4.  Are there any issues that we have not addressed which might

 be of interest?

THANKS FOR YOUR TIME AND EFFORT IN SHARING YOUR EXPERIENCES

WITH US.